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The Brexit Bungle - Availability and storage of medicines and foodstuffs in a no-deal Brexit UK

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The Brexit Bungle: Prepare for the worst, hope for the best.

Effects on supply and storage of medical supplies and foodstuffs in the event of a 'No Deal' Brexit.

Many of you by now will be fed up to the teeth of reading and listening to the news media about that dreaded word, 'Brexit'! - I cringe every time I hear that word, let alone type it!
Whatever your take on the E.U. 'stay' or 'leave' concept, there will be major issues arising, especially so if there is a 'no deal' agreement.
The main thrust of this article (written 8 January 2019), is to concentrate on the probable scenario of the lack and shortages of resources caused by a no deal Brexit, especially medicines and imported foodstuffs, and the issues raised in storing such items.

I have collated the information under various sections; Effects of a no deal Brexit; contingency plans; effects of the shortage of medicinal supplies, and the related storage problems. Foodstuffs I will include in part 2 of the article, but as we are fast approaching this 'bungle;' I consider the medical/drug supplies issue of great importance, and thus I regard this as an imminent priority.

Prior to reading the article, here are a few related quotes on a 'No-deal Brexit'

A no-deal Brexit would mean the biggest disintegration of the complex regulated medicines market in Europe.

Laura Collisten Bio Industry Association



Harmful drug shortages will worsen after Brexit

British Medical Journal 2018



Two minutes more transit time per lorry at Dover and the Channel Tunnel translates into a 47 kilometer traffic jam

Imperial College London



37 million medicine packs are imported into the UK from the rest of the EU each month, while 45 million packs are exported.

The Pharmaceutical Journal 2018



More than two-thirds of the land needed to produce UK's food and feed is based abroad.

The Guardian July 2018



If community pharmacy is asked to stockpile drugs it could 'bust the system'

RPS president Ash Soni



It could be a reality if we don't get our act together, we can't suddenly start manufacturing insulin -its got to be sorted, no question.

Sir Michael Rawlins chair of Medicine and Healthcare products



Before we delve into the practicality of what type of medical supplies and foodstuffs will be in short supply in the early days of Brexit, and the complexities of long-term storage of these supplies, let's take a look at some of the facts/predictions by recognised journals and organisations.


'The Economist' (November 2018) 'Free Falling' What to Expect from a No Deal Brexit'


50% of the fish caught in British waters are exported to the E.U. - what will happen to this amount of fish when we exit? Will they rot on the quayside?




Imperial College, London, have calculated that two minutes more transit time per lorry at Dover and the Channel Tunnel, translates into a 47 kilometer traffic jam
While the British government has contingency plans for turning a 20 kilometer stretch of the M20 motorway which runs through Kent to Dover, into a multi-lane lorry park.



Currently, British trucks carry goods between any two points in the E.U. After a n-deal Brexit, haulage would instead be subject to the Vienna Convention on Road Traffic of 1968. This will allow Britain to issue up 1,224 of the country's 75,000 lorries with permits for travel between Britain and the E.U every year. To avoid a spectacular failure of the transport infrastructure Britain will need unilaterally to allow E.U Lorries into Britain, which will not please its native hauliers. Even so, prices will go up and capacity will shrink.



Britain's big supermarket chains hold as little as one-and-a-half day's worth of fresh food in their supply chain at any given time, and say they have no capacity to hold more.

A n-deal Brexit would also disrupt the supply of medicines and medical services. Mike Thompson, head of the Association of the British Pharmaceutical Industry, says the industry has been on notice since July to accelerate its preparation for no deal. Stocks of medicines have been increased; Novo Nordisk, a Danish firm, is doubling the insulin is has on hand to guarantee a 16-week supply. However, in October MP's were told there were simply not enough cold-chain warehouses to ensure supplies of drugs that need a constant temperature from manufacture to injections. Drug companies working with the government have recently been prevented from talking about the planning needed by strict gagging clauses.

If Britain left the E.U with no deal, airlines would no longer be able to fly between the two without some new agreement.


And neither British airlines nor European ones would necessarily be able to fly between Britain to America: the open-skies agreement between America and the E.U would cover neither post-Brexit British companies nor European airlines flying to America from a non-E.U country.

France says that, legally speaking, all Britons living there after a no-deal Brexit would need work permits, and that employers with Britons lacking such permits on the payroll would be criminally liable.



According to the Guardian (October 2018), a no-deal Brexit could mean cancelled NHS operations, delays in diagnosis and long-term pressure on staffing numbers. In addition, the set of 30 documents released under the freedom of information requests provide a detailed portrait of contingency planning for Brexit in NHS Scotland and Wales:


They say it could take years to train enough staff to replace departing EU nationals, increasing the burden on the health service at a time when staff shortages are already starting to bite. They also suggest the consequences for patients could be serious if vital medical supplies are held ip.


While on Sky News (August 2018) an investigation has found that nearly 30 councils are formulating their own emergency plans because of Brexit uncertainty, including border controls, the availability of food and medicines and even 'social unrest'.



In addition, the Joseph Rowntree Foundation, shows that 19 million people are already living below the benchmark for an adequate income because of rising food and fuel prices (Guardian August 2018).


We now look at some of the views and commentary from the professional pharmaceutical organisations, to see what they say on the Brexit scenario.


'Stockpiles, Shortages and Supply Chains: What a no-deal Brexit may mean for the Pharmacy'

The Pharmaceutical Journal (August 2018).

You can expand the shelf life of salad, but you can't do that with medicines – which are unique and vulnerable.
Ash Soni, President of the Royal Pharmaceutical Society.

Disruption to the supply chain is one of the ways that patients could be seriously disadvantaged. It could be a reality if we don't get our act together. We Can't suddenly start manufacturing insulin – it's got to be sorted, no question.

Sir Michael Rawlins, chair of the Medicines and Healthcare products Regulatory Agency, the UK drugs safety watchdog..


Drug manufactures have also said they are taking action, with Sanofi announcing that it is increasing its UK stocks by an extra 4 weeks' worth, allowing for a 14 week supply of medicines based on its own 'internal assumptions of potential delays around a no-deal scenario.


Insulin is clearly at risk, as Rawlins told The Pharmaceutical Journal, because so little is manufactured in the UK. The Brexit Health Alliance, which includes the Academy of Medical Royal Colleges, the NHS Confederation and many other health- related organisations, believes patient access to a prostate cancer medicine, which has not be named, is another drug likely to be at high risk of shortages.


If community pharmacy is asked to stockpile drugs it could 'bust the system' – says RPS president Ash Soni.


The Company Chemists Association (CCA) predicts that any drug with 'complex storage needs and high-volume usage' would be vulnerable.

In addition, the UK could lose all access to all EU networks, including the European Medicines Verification System, after Brexit..


A 'no-deal' Brexit would mean the biggest disintegration of the complex regulated medicines market in Europe.
Laura Collister, BioIndustry Association.


For example, medicinal insulin, used my millions of diabetes patients – including the UK prime minister Theresa May – is not manufactured in the UK, nor is it easily stored, as it requires temperature-controlled conditions. The medicine is partly produced and packaged in the EU, and a disruption to the supply chain due to a no-deal Brexit 'is one of the ways that that patients could be severely disadvantaged' (Michael Rawlins, chair of the MHRA)


Harmful drug shortages will worsen after Brexit, doctors warn.
BMJ 24 September 2018

No-deal Brexit 'will force up price of generic drugs'

HSJ- for Health Care leaders 26 September 2018


The UK's plan to leave the European Union (EU) and the EU's single market could have serious implications for patients' access to medicines and medical technologies.



Certain medicines and medical technologies may be delayed in reaching patients or may even become unavailable to patients if no solution for medicines and medical devices is found during the Brexit negotiations.

NHS European Office 31 October 2018 'Access to Medicines and medical technologies'

Brexit: Chemists could get emergency powers to swap drugs and dosages to prevent shortages under a no-deal outcome.
Independent 7 December 2018


Now that we have some background as to the probable situation regarding medical supplies in a no-deal outcome, we now look at the availability and storage of vital medical supplies. In the first section we look at the information provided by local authorities and companies, while in the second section we take a look at what it means to the individual and what they can do to store their medications.


NHS Dorset Agust 2017:


Medicines Standard E1: Storage and safe custody of medicines (including temperature monitoring)



All medicines must be stored in the original manufacturer's original packaging/container. Medicines should not be transferred from one container to another or left loose. Failure to store the medicine in the original container can effect the integrity of the medicine.........Cupboards should not be sited where they be subjected to higher than average humidity or temperature.

The medicines refrigerator must maintain temperatures between 2 degrees C and 8 degrees C.

Full references in bibliography at the end of this article



Medline Plus: Storing your medicines:

Many factors can damage your medication, including heat, air, light and moisture. Exposure pf medication to inappropriate conditions may render them ineffective, or even harmful if ingested.

HOW TO STORE YOUR MEDICATIONS.

Every medication has its own recommended storage conditions – from room temperature, to refrigeration, to freezing, therefore it is advisable to check with your Pharmacist about any specific storage instructions. The majority of medications may be stored at room temperature, in a cool dry place. It is best to avoid the bathroom medicine cabinet, since heat and moisture from your shower, bath and sink may damage your medicine. It is also advisable to avoid the kitchen, since heat from the stove, sink and any hot appliances can also damage your medicine.


Common medications with special storage requirements include insulin and liquid antibiotics. Insulin is stable at room temperature for 28-30 days, and insulin that will not be used within that period or any medication that requires refrigeration must be kept cool if you are travelling, such as the use of a chilled thermos.



Diabetes UK How to store insulin.

The insulin that you are currently using can be kept at room temperature (under 25 C), which makes it more comfortable to inject.

The best place to store most types of insulin you are not currently using is in the fridge. Don't put it too close, or in, the freezer compartment.

Top tips for storage:

Keep spare vials or cartridges of insulin in their boxes in the fridge

Check the pack for expiry date

Don't expose insulin to sunlight or high temperature, so no leaving it in the car on a hot day or near the cooler.

Expiration guidelines:

An open insulin bottle, or cartridge, or pen is only good for a limited time. Follow these guidelines for discarding insulin:

Glargine (Lantus): Discard opened bottles, pens and cartridges 28 days after you have started to use them.

Lispro (Humalog): Discard open bottles, pens and cartridges 28 days after you have started to use them.



NPH: Discard opened bottles after 42 days. Discard pens and cartridges 14 days after you have used them


All insulin: Discard unopened bottles, pens and cartridges when they reach the expiration date listed on the medicine.

Very Well Health – How to store your insulin.

Keep your insulin out of direct sunlight. Shield it I an area where it will not get sun through a window, whether it is open or closed.

Don't keep your insulin next to a heater or heating vent as that area may reach the temperature danger zone

Your car is a hazard for 'room temperature'. It can get cold in winter weather and freeze your insulin.

Independent diabetes Trust'


Each time you use your insulin, check the bottle to see if it looks normal. Regular insulin should not have particles or be discoloured. NPH or lente insulin should be checked for frosting crystals on the inside of the bottle, as well as clumps. Don't use insulin that looks suspicious.


Wockhardt UK, formerly CP Pharmaceuticals, manufacturers of natural pork and beef insulins, say:


Our recommendation is that a single vial may be used repeatedly over a 3 month period, as long as the vial is maintained at the correct storage temperature of 2 to 8 degrees C.

If the vial is stored outside the refrigerator, at room temperature, then the period of use should be reduced to 28 days.

There are no insulins that mimic the human body's production of insulin in response to food intake..........


Each person responds to insulin in different ways.


There are many variables that affect diabetic control, such as:

Diet and exercise
Lifestyle
Fears of low blood pressure (hypoglycaemia)
Emotions and stress


It is also important to realise that if we have been using 'old' insulin that has gone off, with a change to a new fresh fully effective vial, there is a greater chance of a severe hypo at the changeover time.


Shelf life of drugs: Health Harvard University -Staying healthy, drug expiration dates, do they mean anything?

The big question is, do pills expire?............if expired, do you take the medicine or not?.....

A column published in 'Psychopharmacology Today' offers some advice.

It turns out that the expiration date on drugs does stand for something, but probably not what you think it does. Since a law was passed in 1979, drug manufacturers are required to stamp an expiration date on their products. This is the date at which the manufacturer can still guarantee the full potency and safety of the drug.

From a study conducted by the Food and Drug Administration at the request of the military…....The military faced tossing out and replacing its drugs every few years. What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date.


A rare exception to this may be tetracycline, but the report on this is controversial among researchers.........Excluding nitroglycerine, insulin and liquid antibiotics, most medications are as long-lasting as the ones tested by the military. Placing the medication in a cool place, such as a refrigerator, will help a drug remain potent for many years.


Part 2 Foodstuffs. Supply and storage coming soon.







Bibliography and Internet references.



Listed in order of referenced in the above article

Accessed on 5th to 7th January 2019.



'The Economist' 24 November 2018

http://www.economist.com/briefing/2018/11/24/what-to-expect-from-a-no-deal-brexit


The Guardian 28 October 2018

www.theguardian.com/society/2018/oct/28/no-deal-brexit-may-mean-cancelled-operations-and-staff-shortages-nhs-scotland-wales


Sky news August 2 2018



The Guardian 2 August 2018



The Pharmaceutical Journal 22 August 2018

www.pharmaceutical-journal.com/news-and-analysis/features/stockpiles-shortages-and-supply-chains-what-a-no-deal-brexit-might-mean-for-pharmacy/20205324.article?firstPass=false



Companies Chemists Association CCA



The Scientist – 12 October 2018

www.the-scientist.com/news/opinion/the-uk-pharmaceutical-industry-braces-for-brexit-64926



British Medical Journal 24 September 2018 on harmful drug shortages

www.bmj.com/content/362/bmj.k4040/rr



HSJ for Health Care Leaders 26 September 2018

www.hsj.co.uk/pharmaceuticals/executive-no-deal-brexit-will-force-up-price-of-generic-drugs/7023454.article



NHS European Office 31 October 2018

www.nhsconfed.org/regions-and-eu-/nhs-european-office/brexit-and-the-nhs/brexit-implications-for-health-and-care/access-to-medicines-and-medical-technologies



GOV-UK 23 August 2018 (updated 3 January 2019)

www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal



Independent 7 December 2018

www.independent.co.uk/news/health/brexit-no-deal-medicine-prescription-drug-stockpiling-shortages-nhs-matt-hancock-health-a8672021.html



WHO – storage of medicines guidelines

http://apps.who.int/medicinedocs/en/d/Js4885e



DS Medical drug storage

www.dsmedical.co.uk/blog/how-to-store-your-medical-supplies-at-home



NHS Dorset August 2017 – Medicines Standard

www.dorsetccg.nhs.uk/wp-content/uploads/2018/04/Standard-E1-storage-safe-custody-of-medicines.pdf



Medline Plus Storing your medicines

https://medlineplus.gov/ency/patientinstructions/000534.htm



Diabetes UK

www.diabetes.org.uk/guide-to-diabetes/teens/me-and-my-diabetes/getting-my-glucose-right/insulin/storage



Very Well Health – Insulin storage

www.verywellhealth.com/best-way-to-store-insulin-3289554





Independent Diabetes Trust

www.iddt.org/about/living-with-diabetes/storing-insulin



Harvard University – Shelf life of drugs

www.health.harvard.edu/staying-healthy/drug-expiration-dates-do-they-mean-anything